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0 21CFR Part 11 Assessment

Purpose: This assessment details compliance with 21CFR Part 11 for Electronic Records and Electronic Signatures, and system security. Background: Xxxx [deliberately obscured] has developed hard-copy based and electronic paperless records. Xxxx maintains strict procedures in-line with best practices for controlling IT systems, infrastructure, data, as well as electronicallystored records. Strict provisions include password protection, data backup, and business continuity policies as follows:

Data Security Policy Data Protection & Export Compliance Policy IT Controls & Business Critical System Policy Acquisition and Software Licensing Policy Ethical Policy

These policies are in place to ensure copies preserve the content and meaning of all Records, and minimize business risk. We have implemented policies that are mandated by our corporate parent that require our IT systems to be accessed only by authorized individuals. Acceptance Criteria: The Oracle ERP system must comply with provisions of 21CFR Part 11 that specifically address all phases of electronic records including creation, modification, archiving, and retrieval. Requirement Reference: Code of Federal Regulations Title 21, Volume 1, Parts 1 to 99 Revised as of April 1, 2000 From the U.S. Government Printing Office via GPO Access CITE: 21 CFR 11.1 Page 113-114 TITLE 21FOOD AND DRUGS PART 11- ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

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21CFR Part 11 Assessment (cont.)

Subpart AGeneral Provisions Sec. 11.1 Scope (a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Oracle is an industry-standard and proven database solution designed for administration of resources, data and tasks associated with accurate and repeatable manufacture of xxxxxx. The system has the ability to eliminate traditional paper and hand-written signatures, instead with electronic records and user/time-stamped revision storage. Controls are suitably designed to achieve our security objectives to ensure data authenticity. All controls have been placed in operation and operating effectively. (b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. Oracle is developed to address all phases of company records-creation, modification, archiving, and retrieval. Oracle is not intended for the transmission of records. (c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997.

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21CFR Part 11 Assessment (cont.)

There are no electronic signatures associated with the system. Oracle does store and retrieve dynamic copies of electronic records. (d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with 11.2, unless paper records are specifically required. Oracle electronic records permit paper reduction and labor reduction. Xxxx has implemented strict provisions to defend stored data by ensuring electronic record availability, integrity, authentication, and non-repudiation. (e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. Xxxx agrees with this requirement; Oracle is capable of full audit trails, with recall of who and when data records were entered into the system. Sec. 11.2 Implementation (a) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. Oracle uses electronic records for the storage and manipulation of business, administrative and quality processes. We comply fully with the requirements of this part by means of privilege-driven access to data, audit trails for access to data revisions, and software-based safeguards (such as locking out a user) to prevent records revision.

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21CFR Part 11 Assessment (cont.)

(b) For records required to be maintained but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that: (1) The requirements of this part are met; and Oracle uses electronic records for the storage and manipulation of business, administrative and quality processes. We comply fully with the requirements of this part by means of privilege-driven access to data, audit trails for access to data revisions, and software-based safeguards (such as locking out a user) to prevent records revision. (2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission.) Xxxx, at this time, does not plan to electronically submit to FDA documents relating to business, administrative or quality processes.

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21CFR Part 11 Assessment (cont.)

Sec. 11.3 Definitions (a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part. (b) The following definitions of terms also apply to this part: (1)Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321393)). (2)Agency means the Food and Drug Administration. (3)Biometrics means a method of verifying an individual's identity based on measurement of the individual's physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. Oracle does not use Biometrics to identify or verify identity. (4)Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. Oracle is a closed system. (5)Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. Oracle does not use digital signatures as a method of originator authentication. (6)Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. The Xxxx Oracle ERP system supports the above records.

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21CFR Part 11 Assessment (cont.)

(7)Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature. Oracle does not use digital signatures as a method of originator authentication. (8)Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark. Xxxxs Oracle system does not currently use these electronic devices to capture a signature. (9)Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. Xxxs Oracle is a closed system.

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21CFR Part 11 Assessment (cont.)

Subpart BElectronic Records Sec. 11.10 Controls for closed systems Persons who use closed systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: (a) Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Oracle users are uniquely identified using login user name and passwords. Password validation clearly identifies the user as the authorized person to make changes to documents. In the event of a change or revision to stored records, the identity of the person making the changes, as well as date and time of the revision is stored are clearly available to system administrators and management. Xxxxs IT policies also require that the user PC is locked down in the event the user leaves their workstation or after inactivity. The system also uses operating system controls, database control, and directory access controls to ensure authenticity and integrity of records. (b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records. Oracles embedded tools facilitate accurate and complete copies of records. The reports can be printed, faxed and sent as an unmodifiable Adobe pdf format for email. These features are privilege-driven.

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21CFR Part 11 Assessment (cont.)

(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period. Xxxx stores electronic records for an indefinite period, with full access. Our record protection exceeds requirements with standard processes and best practices including: Layered security including network access controls Strategic Disaster Recovery plans Redundant data storage Off-site archival procedures

(d) Limiting system access to authorized individuals. We ensure Oracle access to authorized individuals through 1) Network Login/Password; 2) OS Folder/File access restrictions (Read Only access); and 3) Oracle Login/Password (see graphic below).

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21CFR Part 11 Assessment (cont.)

(e) Use of secure, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying. Xxxxs Oracle system supports user and time stamp auditing to emphasize audit trails, to ensure record changes do not obscure previously recorded information. The audit records and readily accessible and include the following:

Date and time of record change User who caused the event to occur Type of event Success or failure of the event The computer request origin (i.e. computer name and/or IP address)

(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. Oracle enforces steps and events sequencing using proven logic scripts and proprietary controls which are not able to be defeated. (g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand. Oracle employs strict authority checks at Login and then during modification of the database, which ensures only authorized individuals use the system and access an operation. (h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction.

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21CFR Part 11 Assessment (cont.)

Oracle relies on workstation specific security measures such as Network Login/Password protection. (i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks. Xxxx IT professionals average 10 years experience in software development and administration, with relevant experience in a regulatory environment. Our service contract with Oracle allows factory-trained representatives to provide additional administrative support, as needed. (j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. Oracle does not use digital signatures as a method of originator authentication. (k) Use of appropriate controls over systems documentation including: (1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. Xxxxs extensive training permits effective use of our Oracle ERP system. We have developed custom user guides with screen shots, which we use as training materials. These documents are available to the user community, and are currently stored on our P:\ directory. (2) Revision and change control procedures to maintain an audit trail that documents time-sequenced development and modification of systems documentation. Xxxx fully complies with change control procedures under xxxxx Change Control Policy.

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21CFR Part 11 Assessment (cont.)

Sec. 11.30 Controls for Open systems Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality. Oracle is a closed system. Sec. 11.50 Signature manifestations (a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. (b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). The Oracle system does not utilize electronic signatures. Sec. 11.70 Signature/record linking Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.

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21CFR Part 11 Assessment (cont.)

Subpart CElectronic Signatures Sec. 11.100 General Requirements (a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. The Oracle system requires a unique login and passwords for each user. Xxxxs IT policies, procedures and training assures that login and passwords are never reused or assigned to others. In Oracle each user is always unique and clearly linked to every database transaction. (b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual's electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual. All Oracle users are associated with a verifiable user, who is an employee of Xxxx, or a person authorized to perform work on behalf of Xxxx. (c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures. Oracle does not utilize electronic signatures. (1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857. (2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer's handwritten signature.

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21CFR Part 11 Assessment (cont.)

Sec. 11.200 Electronic Signature components and controls (a) Electronic signatures that are not based upon biometrics shall: (1) Employ at least two distinct identification components such as an identification code and password. (i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual. (ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. (2) Be used only by their genuine owners; and (3) Be administered and executed to ensure that attempted use of an individual's electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. (b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners. Oracle requires that every database transaction be validated by password authentication. Sec. 11.300 Controls for identification codes/passwords Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include: (a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password. Oracle does not allow duplicate login and password combinations.

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21CFR Part 11 Assessment (cont.)

(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging). Per Xxxx IT procedures, users are required to change/update passwords every 90 days. (c) Following loss management procedures to electronically deauthorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. Currently Xxxxs installation of Oracle does not support token ID cards. (d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management. Unauthorized users cannot login to Oracle. (e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner. Currently Xxxxs installation of Oracle does not support token ID cards.

11.0 Xxxx Oracle ERP Password & Screen Verification

Instructions: Test the graphic displays (screens) associated with the Oracle ERP system to ensure the browser facilitates authentication using login credentials. Challenge the system with a non-recognized Username/Password combination. Verify the software displays the Oracle modules in an easy-tonavigate menu structure. Acceptance Criteria: The screens used for authentication, navigation and display of modules must sequence as specified. Screen Sequence Procedure Launch the Oracle system by launching the IE browser and navigating to the Oracle login screen. Enter a known username, but a non-recognized password. Enter an unknown username and known password. Specified The Oracle Login screen displays and prompts the user to authenticate using Username and Password. Oracle rejects the Login attempt and does not allow access to the system. Oracle rejects the Login attempt and does not allow access to the system. Actual Initials/ Date

Completed By:________________________ Date:_______________________

11.0 Xxxx Oracle ERP Password & Screen Verification (cont.)

Screen Sequence Procedure Attempt Login with the correct username and Password credentials. Upon login verify the Navigator directory screen appears, with access to the modules within Oracle. Specified Oracle accepts the Login and allows access to the system. The Navigator directory screen displays, with access to modules. Actual Initials/ Date

Completed By:________________________ Date:_______________________